Research Ethical Approval

Eti Nurwening Sholikhah

Department of Pharmacology & Therapy

Faculty of Medicine, Public Health and Nursing
Universitas Gadjah Mada Yogyakarta

Medical and Health Research Ethics Committee Faculty of Medicine

UGM – RSUP DR Sardjito Yogyakarta
Which research need ethical
approval?

1. Research Involving Human

2. Research involving Animal
 Learning Objectives

1.Understand the principle of research

ethics
2.Understanding step to submit ethical
approval for research
EC (Ethics Committee)
IRB (Institutional Review Board)

An independent body - review board or committee,

institutional, regional, national, or supranational (Names of
committees vary by location)

Constituted of medical/scientific professionals and non-

medical/scientific members

Responsible for ensuring protection of rights, safety and

well being of human subjects; provide public assurance of
the protection by

Review
approval of protocol,
suitability of investigators,
Facilities
methods and materials of obtaining Informed Consent
 IRB Review

PURPOSE

A. SCIENTIFIC REVIEW
Does this research study (Title, Objectives, Study design, Data
collection process, analysis plan) have the potential to yield
useful information ?

A. ETHICAL REVIEW
Does this research study have adequate concern for the safety
and welfare of its subjects ?
 IRB/IEC Responsibilities
Prime directive is to safeguard the rights, safety, and well-being of all
trial subjects with special attention to vulnerable subjects

Review documents (provided by the Investigator)

•Protocol/ protocol amendments

•Patient information sheets, Consent forms/ updates
•Subject recruitment procedures (advertisements)
•Investigator Brochure
•Safety information
•Payment for subjects
•Investigators’ CV
Ethical Guidance for IRBs/IECs
1. International Guidelines
– Helsinki, Belmont, CIOMS, etc.
2. National Laws and Guidelines
3. Standard Operating Procedures
– WHO Operational Guidelines for Ethics
Committees That Review Biomedical Research
– ICH-GCP
4. Requirements for international assurances
– Federal wide Assurance (FWA), etc.
Medical and Health Research Ethics Committee (MHREC)
Faculty of Medicine Public Health and Nursing
Universitas Gadjah Mada –
Dr. Sardjito General Hospital

• Address:
– Gedung Radiopoetro Lantai II,
Jl. Farmako Sekip Utara, Yogyakarta 55281
Indonesia
• Contact:
– Tel.: +628112666869
– Email: [email protected]
– Website: http://komisetik.ifk.ugm.ac.id
 MHREC
Faculty of Medicine Universitas Gadjah Mada –
Dr. Sardjito General Hospital

Since 2012 :
Recognized by The Forum for Ethical Review Committees in the Asian and
Western Pacific Region (FERCAP)

Since 2012:
Federal Wide Assurance (FWA): Office for Human Research Protections
(OHRP) USA  IORG0007180

2015, 2019, 2023 :

Re-visit for accreditation (recognized) by The Forum for Ethical Review
Committees in the Asian and Western Pacific Region (FERCAP)

2023:
Accredited by KEPPKN (Komite Etik Penelitian dan Pengembangan Nasional)
 Submission
Review
Preparation by
process
researcher
Preparation (Documents)

Institution Letter
Protocol
Patient information form
Informed consent form
Advertisement
Investigator brochure
Case report forms (CRF)
Research team list
CVs
GCP certificates
Study budget
Submission

method
Online
Management of Protocol Submissions

No ACTIVITY PERSON(S) TIMELINE

RESPONSIB
LE
1 Receive the initial protocol package for review and Secretariat To be done
check the completeness of the protocol package staff within 5
submitted through MHREC online submission system working days

2 Assign a permanent code to the protocol package Secretariat

staff
3 Send notification on the completeness of the Secretariat
submission through email and online submission staff
system
4 Forward the documents to the panel’s secretary Secretariat
staff
5 Determine type of review and assign primary reviewers Secretary

6 Forward the documents to the reviewers Secretary

7 File the protocol and all protocol related documents Secretariat

staff
Review Process

Exempted
No risk

Type of
Expedited
Review low risk
exeperiment

Fullboard
Mild-high risk
Type of
Review Exempted

No risk or negligible
risk
Exempt Research
 Research conducted in established or commonly accepted educational
settings, involving normal educational practices
 Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior, UNLESS:
 Information obtained is recorded in such a manner that human subjects
can be identified, directly or through identifier linked to the subjects
 any disclosure of the human subjects’ response outside the research could
reasonably place the subjects at risk of criminal or civil liability or be
damaging to the subjects financial standing, employability or reputation
 Research involving the collection or study of existing data, documents,
records, pathologic specimens, or diagnostic specimens, if these sources
are publicly available or if the information is recorded by the investigator in
such a manner that subjects can not be identified, directly or through
identifiers linked to the subjects.
 Research using microbes, cell lines or other materials that do not have
direct/ indirect link to human subjects
 Research using animal which is not included in to mammalian
 Exempt from Review
No ACTIVITY PERSON(S) TIME LINE
RESPONSIBLE
1 Review eligibility of a study secretary To be done
protocol for exemption from within 10
review working
2 Issue Exemption Letter or Chair days
recommend expedited or full-
board review
3 Prepare a report of protocols Secretariat
that are exempt from review staff
to full-board
4 Communicate the MHREC Secretariat
decision to the investigators staff
5 File the documents Secretariat
staff
Type of Expedited
Review low risk

The protocol need to be reviewed by at least 2

reviewers appointed by the secretary (in accordance
with the Ethics Commission SOP) without having to be
discussed at a regular meeting.which is attendedat a
minimum of a quorum of panel members (Fullboard)

The protocol can be given an exemption letter

Expedited review - Minimal/low risk health research that requires
personal information:
 Research involving animal (mammalian)
 About a topic that should not result in causing social stigma
 Does not involve vulnerable populations
 Retrospective studies using anonymized data from medical records
 Studies using simple questionnaires without identifiers
 Laboratory research that uses anonymized human tissue/specimen
 Proposals involve interviewing of a non-confidential nature (not of a
private e.g. relate to sexual preference etc.), not likely to harm the
status or interests of the individual and not likely to offend the
sensibilities of the people involved.
 Those that involve collection of small amounts of blood samples
(and not too frequent)
 Those that involve collection of biological specimens for research
purposes by non-invasive means (e.g. collection of body fluids or
excreta non-invasively, collection of hair or nail clippings in a non-
disfiguring or non-threatening manner).
 Collection of data for research purposes through non-invasive
procedures (not involving general anesthesia or sedation), routinely
employed in clinical practice and using medical devices which have
been already approved for use. Examples of such procedures include
collection of data through application of EEG or ECG electrodes,
acoustic testing, tests using the Doppler principle, non-invasive blood
pressures and other routine clinical measurements, exercise tolerance
etc. However procedures involving the use of x-rays or microwaves are
NOT recommended for expedited review. Where medical devices are
employed, they must be cleared/ approved for marketing.
 Research involving data, documents or specimens that have been
already collected or will be collected for ongoing medical treatment or
diagnosis, such as data from medical records
Expedited review
NO ACTIVITY PERSON(S) TIMELINE
RESPONSIBLE
1 Determine whether the submission qualifies for secretary 5 working
expedited review days
2 Assign primary reviewers (medical/scientific and a non secretary
medical/non scientific members)
3 Send the protocol package to primary reviewers secretary

4 The primary reviewers review the documents using the Primary 10

study protocol assessment forms reviewers working
days
5 Return the completed assessment forms to the Primary
Secretariat reviewers
6 Collate and reviews the review results from the primary secretary/ 5 working
reviewers to take appropriate action secretariat days
staff
7 Communicate MHREC decision to the investigators Secretariat
staff
8 Prepare a list of all expedited review results and report Secretariat
to the next full board meeting staff
9 File the documents Secretariat
staff
 Type of
Fullboard
Review
Mild – high risk

Protocols need to be reviewed by at least 2 reviewers who

are appointedby the secretary (in accordance with the
SOP of the Ethics Commission) and continued to be
discussed at a regular meeting attended by at least a
quorum of ethics commission members or an ethics
commission panel.

Researchers may be invited to this meeting

 Human health research involving medium to high risks to
human participants
 Intervention studies involving experimental treatments
like clinical trials
 May involve vulnerable populations who should be
protected
 Involves private information that may cause stigma
 Genetics studies
 A study involving sensitive/ confidential information, i.e.
sexuality/ reproductive health, sexually transmitted
diseases, genetic studies and other information that may
cause embarrassment and damage to the subjects’
reputation, such as psychiatric/ psychologic condition,
leprosy, etc
 Full board review
NO Activity PERSON(S) TIME LINE
RESPONSIBLE
1 Determine if the submission should secretary 5 working days
undergo full-board
2 Assign primary reviewers secretary
3 Send the protocol package through online secretary
system to the primary reviewers
4 Review the documents with protocol Primary 10 working
assessment forms reviewers days
5 Return the completed assessment forms to Primary
the secretariat reviewers
6 Discuss and decide on the protocol and chair The next full-
related documents during a convened full board meeting
board meeting
7 Communicate MHREC decision to the PI Secretariat staff 5 working days

8 File the protocol and all protocol related Secretariat staff

documents
The Protocol Assessment Form allows review of the technical
and ethical issues, e.g:
 Rationale and significance of the study
 Objectives of the study
 Sample size
 Methodology and data management
 Inclusion/exclusion criteria
 Control arms (placebo, if any)
 Withdrawal or discontinuation criteria
 Vulnerability determination
 Risk/ benefit assessment
 Review the qualifications of the PI and the research team to
include the following:
 Education and speciality
 GCP training (if necessary)
The Informed Consent Assessment Form enables review
of the following:

 Full disclosure of information, including risks

 Benefits that may be derived from the study
 Use of understandable language, with appropriate
translation
 Voluntary participation
 Confidentiality
 Appropriate person to sign the consent form
 If an Assent Form is required, it should be reviewed
to ensure that the proper form is available, and the
appropriate signature is required.
 Final Decision
The primary reviewers decide whether the protocol can be

 Approved (when no further modification is required)

 Administrative modification (requires minor changes in the
documents such as typographical errors, administrative issues,
etc.)
 Minor modification (no need a full board review)
 Major modification (requires revision of study design, major
sections of the protocol or ICF that affect patient safety or
credibility of data and need a full board review)
 Disapproved (by full board review only) (due to ethical or legal
concerns) Reasons for vote of disapproval should be noted in the
minutes and communicated to the PI.
The most common
cases
Aspek Etik Penelitian
Penelitian sudah selesai dilakukan, namun
mengajukan ethical approval suatu protokol dan
ditulis bahwa penelitian akan dilakukan setelah
mendapat ethical approval dari komisi etik

Disuruh melakukan penelitian dulu, sambil

mengajukan ethical approval

Protokol ditulis dengan asal-asalan, misalnya tidak

sesuai antara judul dengan isi (terkesan copy &
paste dari protokol lain namun lupa
menyesuaikan)
Dokumen tidak lengkap, misalnya
Penelitian menggunakan kuesioner, namun
kuesioner tidak dilampirkan
Tujuan Penelitian

Tujuan penelitian tidak jelas

(Tujuan yang dituliskan tidak sesuai dengan maksud
peneliti)

Contoh:
Maksud peneliti: untuk mengetahui pengaruh …….
terhadap pengetahuan, sikap, dan perilaku,

Namun tertulis: untuk meningkatkan pengetahuan

Metode

Belum dituliskan kriteria inklusi, kriteria eksklusi, kriteria

widrawl

Menuliskan kriteria eksklusi yang merupakan kebalikan

dari kriteria inklusi
Prosedur penelitian yang tertulis berbeda dengan yang
akan dilakukan
Contoh: Peneliti tidak menuliskan bahwa penelitian
hanya dengan melihat rekam medis.

Salah menyebutkan macam penelitian,

Contoh: Penelitian merupakan penelitian observasional
namun peneliti menuliskan penelitian eksperimen
(namun dalam protokol tidak disebutkan adanya
intervensi)
Jumlah sampel tidak dituliskan, atau dituliskan namun
penghitungan jumlah sampel minimal tidak dituliskan,
atau dituliskan namun rumusnya tidak sesuai.

Tidak menyebutkan tempat pemeriksaan laboratorium

(Perlu disebutkan bila pemeriksaan tidak ada yang
dilakukan ke luar negeri sehingga tidak ada sampel yang
dikirim ke luar negeri)
Informed Consent
Beberapa Istilah masih menggunakan Istilah bukan awam
(medis, ilmiah)

Dalam ICF yang terdahulu, tidak ada pernyataan subyek

bersedia jika sisa sampel yang ada, boleh disimpan dan dapat
digunakan untuk pemeriksaan berikutnya sehingga untuk
penelitian ini harus re-consent

Lembar penjelasan dan lembar persetujuan anak usia 12-18

tahun belum tersedia

Uang transport atau lumpsum tidak disebutkan jumlahnya,

berapa kali diberikan, kapan diberikan
Isi lembar penjelasan yang tertulis dalam protokol berbeda
denagn lembar penjelasan yang terpisah.

Belum disebutkan risiko tindakan penelitian, apa yang akan

dilakukan apabila terjadi risiko atau efek samping, siapa yang
bertanggungjawab

Tidak menuliskan dokter penanggungjawab penelitian

Bila diberikan suvenit, belum menyebutkan souvenir apa yang

diberikan
Penelitian menggunakan media
sosial

Topik penelitian tidak layak untuk diinformasikan melalui media sosial

Belum disebutkan cara menjamin kerahasiaan subyek penelitian

Belum disebutkan cara mendapatkan persetujuan calon subjek

Penelitian terkait stigma (misalnya
pasien HIV/AIDS, TBC)

Perekrutan subyek dilakukan oleh peneliti sendiri,

seharusnya oleh dokter yang merawatnya
Kompetensi Peneliti

Kompetensi tidak sesuai

Penelitian klinik, namun peneliti belum

mendapatkan sertifikat GCP (bukan GCLP)

Sertifikat GCP kedaluwarsa

Penelitian menggunakan
kuesioner baru atau terjemahan

Kuesioner belum divalidasi

Uji klinis Obat

Methods – Belum mengacu pada CONSORT. Dalam metode

penelitian harusnya disebutkan cara randomisasi, blinding,
intention to treat analysis dsb.

Analisis statistik tidak sesuai

Formulir-formulir yang akan digunakan tidak dilampirkan (Misalnya

SOP, Formulir pengamatan, Iklan untuk merekrut subjek)
Risiko penelitian dan cara menanganinya belum dituliskan

Produk atau sediaan yang akan diberikan tidak dibuat oleh industri
atau institusi yang mempunyai sertifikat GMP

Tidak disebutkan kapan monitor pasien dilakukan? Sampai berapa

lama sejak penelitian selesai
Uji Klinis Alat

Keamanan, kemanfaatan, efektivitas belum dijelaskan

parameter dan cara menilainya

Methods
Belum ada informasi
Siapakah yang melakukan /mengoperasikan?
Bagaiman prosedur pengggunaannya?
Kapan dilakukan?
Bukti kelayakan alat untuk digunakan pada pasien

Belum disediakan lembar penjelasan dan lembar persetujuan